Thursday, 27 November 2014

Biosimilars market rises

A
new report suggests that specialty pharmaceuticals are growing in proportion of
total pharmaceutical spend in the United States as well as in cost to the
patient and healthcare system at an unsustainable rate.

Biosimilars
also known as follow-on biologics are biologic medical products whose active
drug substance is made by a living organism or derived from a living organism
by means of recombinant DNA or controlled gene expression methods. Biosimilars
(or follow-on biologics) are terms used to describe officially approved
subsequent versions of innovator biopharmaceutical products made by a different
sponsor following patent and exclusivity expiry on the innovator product.

The
Biologics Price Competition and Innovation Act (BPCIA) of 2009 was enacted as
part of the Patient Protection and Affordable Care Act on March 23, 2010, to
alleviate some of those pressures. It amended the Public Health Services Act to
include an abbreviated pathway in section 351(k) for biological products shown
to be biosimilar to or interchangeable with an FDA licensed reference product.
The BPCIA opened the door for biosimilar versions of already approved biologics
where “generic” competition did not exist prior.

The
FDA continues to clarify biosimilar guidelines. The most recent draft guidance
providing additional details was published on May 2014. In an article for Pharm
Pro, Sarfaraz K. Niazi examines current FDA regulations and explores the state
of the market.